Egalet (EGLT) Says FDA Will Not Meet October 14 PDUFA Date

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Egalet Notified that FDA Will Not Meet PDUFA Goal Data for ARYMO ER

October 13, 2016 6:05 PM EDT

WAYNE, Pa., Oct. 13, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced that the U.S. Food and Drug Administration (FDA) will not meet the previously announced October 14 prescription drug user fee act (PDUFA) date for ARYMO ER (morphine sulfate).

"Today we were informed that the FDA has identified no particular issue with our application for... More